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  5. NDC Package Code: 50914-7729-2 Glofil-125

NDC Package 50914-7729-2 Glofil-125

Sodium Iothalamate I-125 Injection Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50914-7729-2
Package Description:
1 VIAL, MULTI-DOSE in 1 BOX / 4 mL in 1 VIAL, MULTI-DOSE
Product Code:
50914-7729
Proprietary Name:
Glofil-125
Non-Proprietary Name:
Sodium Iothalamate I-125 Injection
Substance Name:
Iothalamate Sodium I-125
Usage Information:
GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease.
11-Digit NDC Billing Format:
50914772902
Product Type:
Human Prescription Drug
Labeler Name:
Iso-tex Diagnostics, Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IOTHALAMATE SODIUM I-125 .275 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA017279
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-01-1983
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50914-7729-2?

    The NDC Packaged Code 50914-7729-2 is assigned to a package of 1 vial, multi-dose in 1 box / 4 ml in 1 vial, multi-dose of Glofil-125, a human prescription drug labeled by Iso-tex Diagnostics, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 50914-7729 included in the NDC Directory?

    Yes, Glofil-125 with product code 50914-7729 is active and included in the NDC Directory. The product was first marketed by Iso-tex Diagnostics, Inc. on May 01, 1983 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50914-7729-2?

    The 11-digit format is 50914772902. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-150914-7729-25-4-250914-7729-02